drugset / Trial / NCT03036852
Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease
NaSingle-groupOpen-labelTreatment
Summary
The primary objectives of this study are to evaluate safety, efficacy, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end stage renal disease (ESRD) with chronic hepatitis C virus (HCV) infection of any genotype.
Timeline
- Start
- 2017-03-22
- Primary completion
- 2018-08-13
- Completion
- 2018-11-07
Publications
- Results Borgia SM, Dearden J, Lurie Y, Shafran SD, Brown A, Hyland RH, et al. Sofosbuvir/Velpatasvir for 12 Weeks Is Safe and Effective in Patients Undergoing Dialysis. American Association for the Study of Liver Diseases (AASLD); 2018 09-13 November; San Francisco, CA.
- Borgia SM, Dearden J, Yoshida EM, Shafran SD, Brown A, Ben-Ari Z, Cramp ME, Cooper C, Foxton M, Rodriguez CF, Esteban R, Hyland R, Lu S, Kirby BJ, Meng A, Markova S, Dvory-Sobol H, Osinusi AO, Bruck R, Ampuero J, Ryder SD, Agarwal K, Fox R, Shaw D, Haider S, Willems B, Lurie Y, Calleja JL, Gane EJ. Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis. J Hepatol. 2019 Oct;71(4):660-665. doi: 10.1016/j.jhep.2019.05.028. Epub 2019 Jun 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sofosbuvir/velpatasvir | Unknown | 100 mg | Oral |
| Subject | Sofosbuvir/velpatasvir | Unknown | 400 mg | Oral |